Characterization of Human Cancers by Molecular Profiling of Patient Biospecimens
试验速览
- 阶段
- 不适用
- 发起方
- Pharmatech
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Identification of oncogenic molecular abnormalities by laboratory testing of tumor tissue
研究概览
简要总结
Purpose of the Protocol:
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To prospectively identify cancer patients whose tumors express specific molecular markers targeted by therapeutic agents, for the purpose of selecting the most clinically appropriate anticancer therapy, including clinical trial opportunities.
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To collect and analyze biospecimens from cancer patients, using primarily standard of care laboratory methods, for the purpose of determining the expression of specific genotypic and phenotypic disease markers of scientific and medical interest.
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To create a protocol database, including case and disease stage-matched clinical and therapeutic history data in addition to patient biomarker profiles, to serve as:
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a systematic collection of data for comparing patient data to clinical trial selection criteria for the purpose of informing a clinical investigative site of available clinical trials matching patient clinical status;
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a collection of clinically matched, comprehensive molecular results for scientific and research and development applications.
详细描述
The molecular understanding of cancer is advancing rapidly, and a new generation of more effective, targeted cancer drugs are taking center stage in cancer care. Yet the investigators system for clinical testing of new agents has not kept pace with the revolution in cancer biology.
Stratification by genotypic and phenotypic abnormalities further divides histological cancers into a myriad of clinically distinct subtypes. As cancer therapies become more selective, and the intent to treat populations and the predictability of patient presentation decrease, clinical trial enrollment becomes more difficult by traditional methods. A breakout solution is needed in clinical research methodology, to create a more efficient means of developing new cancer drugs in the US. Improved methods for the systematic, prospective screening of cancer patients are needed to identify the subsets of patients whose tumors express molecular markers targeted by precision therapeutics. This protocol will evaluate clinical samples of cancer tissue to identify the molecular abnormalities present in individual patients' cancer. In this context the investigators objective will be to enable physicians to more thoroughly characterize the molecular abnormalities underlying cancer and to connect eligible patients to precision treatments as part of optimal care.
By making trials more accessible and utilizing technology wisely, it should be possible to match cancer patients to appropriate treatments, including clinical trials, within a clinically relevant timeframe to bring research opportunities into consideration for best clinical care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have given informed consent in accordance with the methods and procedures of this study
- •Diagnosis of cancer requiring medical care
- •Age ≥18 years
- •Patients under oncology care of a participating site
- •ECOG performance status of 0-3
- •Sufficient clinical status for collection of biospecimen samples within usual care
排除标准
- •Patients considered minors in the jurisdiction where the protocol is conducted
- •Patients who are prisoners
- •Patients who are employees of the research site
- •Relatives of the principal investigator or any participating physician
- •Patients with decisional incapacity who cannot understand or comprehend the informed consent form and therefore cannot give informed consent
结局指标
主要结局
Identification of oncogenic molecular abnormalities by laboratory testing of tumor tissue
时间窗: 60 months
次要结局
未报告次要终点